The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.Source: electronic medicines compendium (emc), DatapharmActive substance: mesalazineOfficial document: view the original leaflet on emc →Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

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Zintasa 400mg Tablets

⚠ This medicine appears to have been discontinued

The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.

If you were prescribed this medicine, other products containing Mesalazine may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.

Active substance: Mesalazine

Equivalent medicines (same active substance, strength and form)

→ Octasa 400 mg modified-release tablets brand

→ Mesalazine Tillotts 400 mg Modified-release tablets

Source: electronic medicines compendium (emc)

Official leaflet: Read the PIL on emc

What it is and what it is used for

for Zintasa EC Tablets contain the active substance mesalazine (also known as 5-aminosalicylic acid) which is an anti-inflammatory drug used in the treatment of: Ulcerative colitis: a disease of the large bowel (colon) and back passage (rectum) in which the lining of the bowel becomes inflamed (red and swollen). Symptoms can include rectal bleeding, frequent diarrhoea and abdominal pain. Zintasa EC Tablets act locally in the colon to reduce inflammation and can also prevent further episodes (flares) of ulcerative colitis. Zintasa EC Tablets can also be used to prevent further attacks of ulcerative colitis. This medicine is sometimes prescribed for other purposes and you should consult your doctor for more information if necessary.

Use of non-steroidal anti-inflammatory drugs (NSAIDs such as ibuprofen, aspirin, Cox-II inhibitors) and azathioprine (used for organ transplant therapy) in particular may increase the risk of kidney reactions. Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Tests on your liver, kidney and blood Before you start treatment with Zintasa EC Tablets you will have a blood and urine test to check how well your kidneys are working and what your blood is doing. During treatment your doctor will check how well your liver, kidney and blood is working by taking blood and urine sample periodically during your treatment. Driving and using machines This medicine is not expected to affect your ability to drive or operate machinery. Important information about Zintasa EC Tablets This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodium-free'.

What you need to know before you take it

e Zintasa EC Tablets TELL YOUR DOCTOR BEFORE TAKING Zintasa EC Tablets:

If you have ever developed a severe skin rash or skin peeling, blistering and/or mouth sores after taking Zintasa EC Tablets. Do not take Zintasa EC Tablets if you:
are allergic to mesalazine or any of the other ingredients of Zintasa EC Tablets (see section 6 – What Zintasa EC Tablets contain).
are allergic to aspirin or any other salicylate.
have had kidney problems or blood abnormalities while taking other medicines such as sulfasalazine.
have severe kidney impairment. DO NOT give the tablets to children under 2 years of age. Warnings and precautions:
Take special care with Zintasa EC Tablets: Serious skin reactions including Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported in association with Zintasa EC Tablets treatment. Stop using Zintasa EC Tablets and seek medical attention immediately if you notice any of the symptoms related to these serious skin reactions described in section 4.
Zintasa EC Tablets should be used with extreme caution in patients with confirmed mild to moderate kidney impairment.
Zintasa EC Tablets should be used with extreme caution in the elderly.
If you become dehydrated (lose too much water), it is important to replace your fluid as soon as possible, contact your doctor or pharmacist for advice. Kidney stones may develop with use of mesalazine. Symptoms may include pain in sides of abdomen and blood in urine. Take care to drink sufficient amount of liquid during treatment with mesalazine. Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach in the toilet water. It concerns a chemical reaction between mesalazine and bleach and is harmless. Other medicines and Zintasa EC Tablets: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Zintasa EC Tablets should NOT be taken with lactulose or similar medicines to treat constipation.

Preventing further episodes of ulcerative colitis – between 3 and 6 tablets each day divided throughout the day, e.g. ○ a daily dosage of 3 tablets may be taken as 1 tablet 3 times a day, ○ a daily dosage of 6 tablets may be taken as 3 tablets twice a day.

DO NOT take more than 6 tablets a day. Your doctor will need to monitor your kidney function prior to starting Zintasa EC Tablets, every three months for the first year, then 6 monthly for the next four years and annually after that. Zintasa EC Tablets are not recommended for use in children. Your doctor may decide to change your dose, it is always important to follow your doctor's directions about when and how to take your medicine. Remember to get a repeat prescription at the right time so that you do not miss a day of treatment. If you take more Zintasa EC Tablets than you should Do not exceed the recommended dose. You should only take as many tablets as your doctor has instructed on the pharmacist's label. If you take too many tablets, or someone accidentally swallows some, tell your doctor immediately or go to your nearest Accident & Emergency Department (take the tablet pack with you if possible). If you forget to take Zintasa EC Tablets If you forget to take a dose at the required time, take it as soon as you remember and continue taking your tablets as before. DO NOT take more than two doses in one hour. If it is almost time for your next dose, wait until then and carry on as before. If you are at all concerned about this, consult your doctor or pharmacist. If you stop taking Zintasa EC Tablets If you suddenly stop taking this medicine your symptoms may come back. You should not stop taking your medicine unless you have been advised to do so by your doctor. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine can cause side effects, although not everybody gets them. If you experience any of the following serious

How to take it

Zintasa EC Tablets Always take this medicine exactly as the doctor has told you. Check with your doctor or pharmacist if you are not sure. The tablets should be swallowed whole with water; do not break, crush or chew them. The usual dose is: Adults and the elderly:

Treating ulcerative colitis – 6 tablets each day divided throughout the day, e.g. ○ 2 tablets 3 times a day, or ○ 3 tablets twice a day. •

Possible side effects

stop taking this medicine and contact your doctor or go to your nearest hospital casualty department immediately: •

reddish non-elevated, target-like or circular patches on the trunk, often with central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes, widespread rash, fever and enlarged lymph nodes. These serious skin rashes can be preceded by fever and flu-like symptoms.

•

• •

•

allergic reaction. Symptoms include skin rash with flaking, boils or sore lips or mouth, lumps or hives, swelling of the face, lips, hands or feet, sudden wheeziness, tightness of the chest or breathing problems. liver problems. Symptoms include feeling tired, feeling sick, pain below the right ribs, your skin or the whites of your eyes turn yellow. changes in your blood. Symptoms include unusual bleeding, bruising, rash, fever, sore throat or excessive tiredness, or you become susceptible to infection. lupus (a disease where the body attacks internal organs such as lungs, heart, stomach and joints). Symptoms include tiredness, fever, joint pain.

Other side effects: Common (may affect up to 1 in 10 people)

headache
feeling sick, being sick, diarrhoea, stomach pains caused by inflammation (swelling, redness and pain) in the intestines. Rare (may affect up to 1 in 1,000 people)
problems with heart, lung, liver or kidney function
inflammation of the pancreas
blood abnormalities
numbness and tingling of the fingers and toes due to damaged nerves
hair loss
fever
skin rash. Very rare (may affect up to 1 in 10,000 people)
worsening of symptoms of colitis
Erythema multiforme and Stevens-Johnson syndrome (skin and mucous membrane disease). Not known (frequency cannot be estimated from the available data)
kidney stones and associated kidney pain (see also section 2)
inflamed lining of the lung, causing sharp chest pain that feels worse with breathing, dry cough, shortness of breath (pleurisy). If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to store it

your Zintasa EC Tablets Keep this medicine out of the sight and reach of children. Store Zintasa EC Tablets at or below 25°C in a dry place and protect from light. Do not take this medicine after the expiry date shown on the label. Do not take this medicine if you notice any visible signs of deterioration of these tablets such as cracks in the coat, take them to your pharmacist for advice. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.

Contents of the pack and other information

What Zintasa EC Tablets contain Each tablet contains 400mg of the active ingredient mesalazine. The other ingredients are microcrystalline cellulose, sodium carboxymethyl starch, corn starch, magnesium stearate, polyvinyl pyrrolidone, mannitol, precipitated silica, dimethyl phthalate, methacrylic acid copolymer, dimethicone, talc, titanium dioxide and red ferric oxide. What Zintasa EC Tablets look like and contents of the pack Zintasa EC Tablets are red-brown, coated and round shaped. The tablets are available in blister packs of 28, 30, 56, 60, 84, 90, 112, 120, 168 or 240 tablets (not all pack sizes may be marketed). Marketing Authorisation Holder Morningside Healthcare Ltd. Unit C, Harcourt Way Leicester, LE19 1WP, UK Manufacturer SOFAR S.P.A., Via Firenze, 40, 20060, Trezzano Rosa (MI) Italy. This leaflet was revised in February 2023.

M0335LAMUKNAB2-P2-003

Frequently asked questions about Zintasa 400mg Tablets

How do I take Zintasa 400mg Tablets?

Zintasa 400mg Tablets comes as tablet containing 400mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.

What is the active substance in Zintasa 400mg Tablets?

The active substance in Zintasa 400mg Tablets is mesalazine.

Are there equivalent medicines to Zintasa 400mg Tablets?

Medicines with the same active substance, strength and form include: Octasa 400 mg modified-release tablets, Mesalazine Tillotts 400 mg Modified-release tablets. They are interchangeable only if your prescriber or pharmacist says so.

Where does this information come from?

This leaflet reproduces the patient information leaflet approved for Zintasa 400mg Tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.

Can I get Zintasa 400mg Tablets without a prescription?

Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.

About this leaflet

The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.

Source: electronic medicines compendium (emc), Datapharm
Active substance: mesalazine
Official document: view the original leaflet on emc →

Medical disclaimer: This page is for information only and does not replace advice from your doctor or pharmacist. Always read the leaflet supplied with your medicine. If you are unwell, call NHS 111; in an emergency, call 999.

Medicines with the same active substance: Mesalazine (31 medicines)

See every medicine containing this substance, or browse the full A–Z of active substances.

⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+

Technical information intended for healthcare professionals (doctors and pharmacists). The Summary of Product Characteristics (SmPC) is the official document approved by the MHRA/EMA. It does not replace the patient leaflet or a doctor’s advice.

4.1. Therapeutic indications

To treat mild to moderate ulcerative colitis and maintain ulcerative colitis in remission.

4.2. Posology and method of administration

Swallow whole with water. Do not break, crush or chew the tablets before swallowing.

Adults:

Acute disease: 6 tablets a day in divided doses, with concomitant corticosteroid therapy where clinically indicated.

Maintenance therapy: 3-6 tablets a day in divided doses.

Elderly:

The normal adult dosage may be used unless renal function is impaired (see section 4.4).

Children:

There is no dosage recommendation.

Route of administration:

Oral.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

A history of sensitivity to salicylates or renal sensitivity to sulphasalazine.

Confirmed severe renal impairment (GFR less than 20 ml/min). Children under 2 years of age.

4.4. Special warnings and precautions for use

Severe cutaneous adverse reactions

Severe cutaneous adverse reactions (SCARs), including Drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), have been reported in association with mesalazine treatment.

Mesalazine should be discontinued, at the first appearance of signs and symptoms of severe skin reactions, such as skin rash, mucosal lesions, or any other sign of hypersensitivity.

Use in the elderly should be cautious and subject to patients having normal renal function.

Renal disorder: Mesalazine is excreted rapidly by the kidney, mainly as its metabolite, N-acetyl-5-aminosalicylic acid. In rats, large doses of mesalazine injected intravenously produce tubular and glomerular toxicity. Mesalazine should be used with extreme caution in patients with confirmed mild to moderate renal impairment (see section 4.3). Patients on mesalazine should have renal function monitored, (with serum creatinine levels measured) prior to treatment start. Renal function should then be monitored periodically during treatment, for example every 3 months for the first year, then 6 monthly for the next 4 years and annually thereafter, based on individual patient history. Physicians should take into account risk factors such as prior and concomitant medications, duration and severity of disease and concurrent illnesses. Treatment with mesalazine should be discontinued if renal function deteriorates. If dehydration develops, normal electrolyte and fluid balance should be restored as soon as possible.

Mesalazine may produce red-brown urine discoloration after contact with sodium hypochlorite bleach (e.g., in toilets cleaned with sodium hypochlorite contained in certain bleaches)

Serious blood dyscrasias have been reported very rarely with mesalazine. Haematological investigations should be performed if the patient develops unexplained bleeding, bruising, purpura, anaemia, fever or sore throat. Treatment should be stopped if there is suspicion or evidence of blood dyscrasia.

Cases of nephrolithiasis have been reported with the use of mesalazine including stones with a 100% mesalazine content. It is recommended to ensure adequate fluid intake during treatment.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. is essentially "sodium-free".

4.5. Interaction with other medicinal products and other forms of interaction

Concurrent use of lactulose and related agents should be avoided as this may lower luminal pH in the colon therefore inhibiting the disintegration of the coating and release of the mesalazine.

Concurrent use of other known nephrotoxic agents, such as NSAIDs and azathioprine, may increase the risk of renal reactions (see Section 4.4).

Possible increased risk of leucopenia when aminosalicylates are given with azathioprine or mercaptopurine.

4.6. Fertility, pregnancy and lactation

No information is available with regard to teratogenicity; however, negligible quantities of mesalazine are transferred across the placenta and are excreted in breast milk following sulphasalazine therapy. Use during pregnancy should be with caution, and only if the potential benefits are greater than the possible hazards. Mesalazine should, unless essential, be avoided by nursing mothers.

4.7. Effects on ability to drive and use machines

Not applicable.

4.8. Undesirable effects

The side effects are predominantly gastrointestinal, including nausea, diarrhoea, vomiting and abdominal pain. Headache has also been reported.

There have been rare reports of leucopenia, neutropenia, agranulocytosis, aplastic anaemia and thrombocytopenia, alopecia, peripheral neuropathy, pancreatitis, abnormalities of hepatic function and hepatitis, myocarditis and pericarditis, allergic and fibrotic lung reactions, pleurisy, lupus erythematosus-like reactions and rash (including urticaria), drug fever, interstitial nephritis and nephrotic syndrome with oral mesalazine treatment, usually reversible on withdrawal. Renal failure has been reported. Mesalazine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment.

Mesalazine may very rarely be associated with an exacerbation of the symptoms of colitis, Stevens Johnson syndrome and erythema multiforme.

Other side effects observed with sulphasalazine such as depression of sperm count and function, have not been reported with mesalazine.

Skin and subcutaneous tissue disorders

Frequency not known:

Drug reaction with eosinophilia and systemic symptoms (DRESS)

Stevens-Johnson syndrome (SJS), Toxic epidermal necrolysis (TEN)

Renal and urinary disorders

Frequency not known: nephrolithiasis*

* See section 4.4 for further information

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

Following overdose, gastric lavage, intravenous transfusion of electrolytes to promote diuresis and standard supportive measures are recommended. There is no specific antidote.

💬 Ask about this leaflet

Ask anything about Zintasa 400mg Tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.

Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.

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